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NCT00099164 · ClinicalTrials.gov registry record · Phase 3
Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS)
A Phase 3 study, sponsored by The George Washington University Biostatistics Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 795
- Enrollment target
NCT00099164 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 795 participants.
The verdict
NCT00099164, a Phase 3 study, has completed, sponsored by The George Washington University Biostatistics Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 795 participants
- Enrollment target
Study Summary
Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a treatment that substantially reduces the rate of preterm birth in women at high risk for preterm delivery (i.e. progesterone therapy). Preterm birth was reduced by 35% among progesterone-treated women with a singleton pregnancy when compared with women receiving placebo. The current trial compares weekly treatment by injection of progesterone with placebo in women pregnant with twins or triplets.
Interventions
- DRUG 17 alpha-hydroxyprogesterone caproate (17P)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 795 participants |
| Start Date | 2004-04 |
| Est. Completion | 2007-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00099164
The ClinicalTrials.gov registry entry for NCT00099164 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 795 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The George Washington University Biostatistics Center, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 17 alpha-hydroxyprogesterone caproate (17P) is the first listed.
NCT00099164 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00099164 about?
NCT00099164 is a clinical study titled "Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS)". Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a treatment that substantially...
What is the current status of trial NCT00099164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 795 participants. The study started on 2004-04. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00099164?
The interventions under investigation include: 17 alpha-hydroxyprogesterone caproate (17P) (DRUG).
Who is sponsoring clinical trial NCT00099164?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
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